Palonosetron (Aloxi)

Section: Injections
Effective Date: August 01, 2019
Revised Date: July 31, 2019

Description

Palonosetron (Aloxi®) is a serotonin-3 (5-HT3) receptor antagonist used as an antiemetic and antinauseant agent used for the treatment and prevention of post-operative nausea and vomiting as well as nausea and vomiting caused by cancer chemotherapy, radiotherapy, and pregnancy. 

Criteria

Coverage is subject to the specific terms of the member's benefit plan. 

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website. 

Food and Drug Administration (FDA) Indications

Palonosetron (Aloxi) may be considered medically necessary in individuals 18 years of age and older when ANY of the following criteria are met: 

  • Prevention of chemotherapy induced nausea or vomiting associated with low or minimally emetogenic cancer chemotherapy for members who have a treatment failure or contraindication to granisetron and ondansetron; or
  • Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses for moderately emetogenic cancer chemotherapy; or
  • Prevention of acute nausea and vomiting associated with initial and repeat courses for highly emetogenic cancer chemotherapy; or
  • Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery, and there is a treatment failure or contraindication to ondansetron. 

Palonosetron (Aloxi) may be considered medically necessary for pediatric individuals 1 month of age to less than 17 years for: 

  • Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. 

National Comprehensive Cancer Network (NCCN) Approved Recommendations

Palonosetron (Aloxi) may be considered medically necessary when used in combination with dexamethasone before intravenous antineoplastic therapy with: 

  • High emetic risk with either aprepitant, fosaprepitant, or rolapitant; or
  • High emetic risk with olanzapine and either aprepitant, fosaprepitant, or rolapitant; or
  • High or moderate emetic risk with olanzapine; or
  • Moderate emetic risk (preferred); or
  • Moderate emetic risk with either aprepitant, fosaprepitant, or rolapitant for individuals with additional risk factors or previous treatment failure with a corticosteroid and 5HT3 receptor antagonist alone. 

Note: May use with or without lorazepam, histamine-2 blockers, or proton pump inhibitors. 

Palonosetron (Aloxi) injection performed for indications other than those listed above will be denied as not medically necessary. 

Procedure Codes

J2469

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

R11.0  R11.10  R11.11  R11.12  R11.2  T45.1X5A  T45.1X5S 
T45.95XA  T50.905A  Z51.11  Z51.12

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